Lixim

Package leaflet: Information for the patient

Lixim, 70 mg, medicated patch
For use in adults
Etofenamate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Lixim is and what it is used for
2. Important information before using Lixim
3. How to use Lixim
4. Possible side effects
5. How to store Lixim
6. Contents of the pack and other information

1. What Lixim is and what it is used for

The active substance in this medicine, etofenamate, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic and anti-inflammatory effects.
Lixim is used for short-term symptomatic local pain treatment in acute, uncomplicated ankle sprains in adults.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

2. Important information before using Lixim

When not to use Lixim:

• if the patient is allergic to etofenamate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to treat pain and inflammation, e.g. acetylsalicylic acid or ibuprofen), which may manifest as asthma, breathing difficulties (bronchospasm), rhinitis, swelling or urticaria;
• if the patient has skin lesions (e.g. abrasions, cuts, burns, open wounds), skin infection or inflammation, exudative dermatitis or rash;
• in women during the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
• on eyes, mouth or mucous membranes.

Warnings and precautions
If a skin rash occurs, remove the medicated patch immediately and discontinue treatment.
To minimize the occurrence of adverse reactions, use for the shortest duration necessary to control symptoms.
Do not use a dressing to secure the medicated patch in place.
Bronchial asthma or allergic patients may experience breathing difficulties (bronchospasm).
During treatment and for 2 weeks after removing the patch, avoid exposing the treated area to direct sunlight or artificial UV radiation (e.g. in a solarium) to reduce the risk of photosensitivity.
Systemic adverse reactions (adverse reactions affecting entire organs, organ systems or the whole body) cannot be ruled out when the medicated patch is applied over large skin areas (i.e. when more than one patch is used - see section 3) and for prolonged periods.
Although systemic effects (effects affecting entire organs, organ systems or the whole body) are expected to be minimal, the medicated patch should be used with caution in patients with:

• impaired kidney, heart or liver function;
• active or past gastrointestinal ulcers, intestinal inflammation or tendency to bleeding.

Particular caution is required when using non-steroidal anti-inflammatory drugs in elderly patients, as they are more susceptible to adverse reactions.
Do not use other medicines containing etofenamate or other non-steroidal anti-inflammatory drugs (NSAIDs), whether applied topically (on the skin) or taken orally, at the same time.

Children and adolescents
Lixim should not be used in children and adolescents under 18 years of age, as the safety and efficacy of this medicine have not been established in this age group.

Lixim and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
When used correctly, etofenamate is absorbed into the body only in small amounts, so interactions with other medicines are unlikely.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
This medicine must not be used in women during the third trimester of pregnancy.
During the first and second trimesters of pregnancy, the medicine may be used only on a doctor's advice.
Small amounts of flufenamic acid, a degradation product of etofenamate, pass into breast milk. However, if considered necessary by a doctor, short-term use of Lixim during breastfeeding may be possible. If Lixim is used during breastfeeding, do not apply it to the breast area, large skin areas or for prolonged periods.

Driving and operating machinery
Lixim has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to use Lixim

This medicine should always be used exactly as described in this patient information leaflet or as
directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly patients
Apply one (1) patch every 12 hours (total of 2 patches per day), for no longer than 7 days.
Only one patch should be used at any given time.
For short-term use only.
Do not exceed the recommended dose.
Method of administration
Topical application.
The patch should be applied only to intact, healthy skin.
How to apply the patch
The patch should be applied to a dry, smooth area of skin. If the skin area where the patch is to be
applied is sweaty or heavily hairy, adhesion of the patch may be reduced.

First, peel off the protective liner from the center of the patch (A) and press this area directly
onto the skin.
Do not touch the adhesive side of the patch with fingers!

Holding the center of the patch (A) with one hand, remove part (B) of the protective liner by folding the patch outward and peeling off the protective liner (B) from the free edge (see arrow). After removing the protective liner, press the patch firmly onto the skin.

Remove part (C) of the protective liner in the same way as part (B). Press the patch firmly onto the skin.
Press the patch onto the skin for at least 30 seconds to ensure proper adhesion.
After using each patch, close the sachet tightly using the drawstring closure.
Duration of treatment
For short-term use only.
Lixim should be used for the shortest duration necessary to relieve symptoms.
Do not use the patch for longer than 7 days. If there is no improvement or if symptoms worsen after this period, consult your doctor.
Do not exceed the recommended duration of treatment.
Use of more Lixim than recommended
In case of overdose or accidental use in children, seek immediate medical advice.
Missed dose
Do not apply a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop using this medicine and contact your doctor immediately if the following occur:

• symptoms of an allergic reaction, such as asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash.
• symptoms of hypersensitivity and skin reactions, such as redness, swelling, peeling, blistering, skin sloughing or skin ulceration.

The following adverse reactions may occur:
Not very common (may occur in up to 1 in 100 people):
Skin inflammation, for example skin redness, itching, burning sensation, skin rash, including with papules, pustules or formation of blisters.
Rare (may occur in up to 1 in 1,000 people):
Hypersensitivity reactions, local allergic reactions (contact dermatitis).
Very rare (may occur in up to 1 in 10,000 people):
Skin swelling.
Frequency not known (cannot be estimated from available data):
Sensitivity to light (photosensitivity).
The risk of adverse reactions increases if the patch is applied over a large area of skin (e.g.
using more than one patch – see section 3) and for prolonged periods.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Lixim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the cardboard
pack: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Do not store above 30℃.
Used patches should be folded in half with the adhesive side inwards and disposed of safely.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Lixim contains

• The active substance is etofenamate. One medicated patch contains 70 mg of etofenamate.
• Other ingredients are:

Adhesive layer
Trimethylsilylated polycrystalline alfa-hydro-omega-hydroxypoly
(dimethylsiloxane) condensate with dimethicone, macrogol 400 and purified olive oil.
Outer protective layer
Polyester.
Protective liner (to be removed)
Polyester coated with fluoropolymer.

What Lixim looks like and contents of the pack
Each patch, measuring 10 cm x 14 cm, is made of white material with a colourless, self-adhesive layer and a removable protective film.
Lixim is available in a cardboard box containing a sealed sachet. Each sachet contains 2, 5 or 7 medicated patches. To allow resealing after removal of individual patches, the sachet is equipped with a re-closing cord.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Drossapharm Arzneimittel Handelsgesellschaft GmbH
Wallbrunnstrasse 24
79539 Lörrach
Germany

Manufacturer/Importer
mikle-pharm GmbH
Sandgasse 17
76829 Landau
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria/Germany: Lixim 70 mg wirkstoffhaltiges Pflaster
Belgium: Lixim 70 mg emplâtre médicamenteux
Lixim 70 mg wirkstoffhaltiges Pflaster
Lixim 70 mg pleister
Spain: Flogopatch 70 mg apósito adhesivo medicamentoso
Hungary: Lixim 70 mg gyógyszeres tapasz
Italy: Dorsiflex
Poland: Lixim
Portugal: Fixplast 70 mg emplastro medicamentoso